FDAFDA · Food and drugs·Recall number Z-1902-2012
MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
Published July 4, 2012 · Recall initiated: May 29, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Discoloration of the acetaminophen enzyme reagent (R1), generates a high calibration factor and erratic control recovery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sekisui Diagnostics Llc
- Distributor
- Illinois
- Lot
- Lot 41928UQ11 {exp 2013-01 -31 )
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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